MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA SUTURECUT ND

Model Number 471309-15

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the 8mm mega suture cut needle driver instrument had broken wires.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) has performed follow-up to attempt to obtain additional information related to the event.However, as of the date of this report, no further details have been provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm mega suture cut needle driver instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/ confirmed the customer reported complaint.Failure analysis found the primary failure of a broken pitch cable to be related to the customer reported complaint.The mega suture cut needle driver instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of this failure is attributed to a component failure and related to device design.A review of the instrument log for the mega suture cut needle driver (471309-15/k132106210127) associated with this event has been performed.Per logs, the mega suture cut needle driver was last used in a procedure on (b)(6) 2021 on system (b)(4).The alleged instrument had 9 uses remaining after the last procedural use.A review of the site's complaint history found that there were no other complaints for this product.No image or video of the last procedure was provided for review.Based on the information provided at this time, this complaint is being reported based on the failure analysis findings.A mega suture cut needle driver instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

• Brand Name: ENDOWRIST
• Type of Device: MEGA SUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13058537
• MDR Text Key: 290153876
• Report Number: 2955842-2021-11791
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119815
• UDI-Public: (01)00886874119815(10)K13210621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471309-15
• Device Catalogue Number: 471309
• Device Lot Number: K13210621 0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.